Biomedix B74 SELEC-3+NIS+LAS IV ADM. SET

GUDID 00851470007132

B74 SELEC-3+NIS+LAS IV ADM. SET

BIOMEDIX-INC

Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set Intravenous administration tubing extension set

• Primary Device ID: 00851470007132
• NIH Device Record Key: a8c0ad02-db12-481e-a205-38c51016cba1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Biomedix B74 SELEC-3+NIS+LAS IV ADM. SET
• Version Model Number: B74-102
• Company DUNS: 798045530
• Company Name: BIOMEDIX-INC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Safe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851470007132 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142097

FDA Product Code

• LHI: Set, I.V. Fluid Transfer

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: true

[00851470007132]

Radiation Sterilization

[00851470007132]

Radiation Sterilization

[00851470007132]

Radiation Sterilization

[00851470007132]

Radiation Sterilization

[00851470007132]

Radiation Sterilization

[00851470007132]

Radiation Sterilization

[00851470007132]

Radiation Sterilization

[00851470007132]

Radiation Sterilization

[00851470007132]

Radiation Sterilization

[00851470007132]

Radiation Sterilization

[00851470007132]

Radiation Sterilization

[00851470007132]

Radiation Sterilization

[00851470007132]

Radiation Sterilization

[00851470007132]

Radiation Sterilization

[00851470007132]

Radiation Sterilization

[00851470007132]

Radiation Sterilization

[00851470007132]

Radiation Sterilization

[00851470007132]

Radiation Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2018-03-29
• Device Publish Date: 2016-09-19

Devices Manufactured by BIOMEDIX-INC

• 00851470007002 - Biomedix B10 SELEC-3 IV ADM. SET: 2018-03-29 B10 SELEC-3 IV ADM. SET
• 00851470007019 - Biomedix B11 SELEC-3+SC IV ADM. SET: 2018-03-29 B11 SELEC-3+SC IV ADM. SET
• 00851470007026 - Biomedix B12 SELEC-3+NIS IV ADM. SET: 2018-03-29 B12 SELEC-3+NIS IV ADM. SET
• 00851470007033 - Biomedix B15 SELEC-3+SC+NIS IV ADM. SET: 2018-03-29 B15 SELEC-3+SC+NIS IV ADM. SET
• 00851470007040 - Biomedix B30 SELEC-3+NIS+LAS IV ADM. SET: 2018-03-29 B30 SELEC-3+NIS+LAS IV ADM. SET
• 00851470007057 - Biomedix B31 SELEC-3+NIS+LAS IV ADM. SET: 2018-03-29 B31 SELEC-3+NIS+LAS IV ADM. SET
• 00851470007064 - Biomedix B32 SELEC-3+NIS+LAS IV ADM. SET: 2018-03-29 B32 SELEC-3+NIS+LAS IV ADM. SET
• 00851470007071 - Biomedix B36 SELEC-3+LAS IV ADM. SET: 2018-03-29 B36 SELEC-3+LAS IV ADM. SET